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UK approves second Covid vaccine targeting Omicron variant UK approves second Covid vaccine targeting Omicron variant
(7 months later)
Pfizer/BioNTech ‘bivalent’ booster, targeting original and Omicron variants, approved along with Moderna jabPfizer/BioNTech ‘bivalent’ booster, targeting original and Omicron variants, approved along with Moderna jab
A second “bivalent” coronavirus vaccine has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for individuals aged 12 and over.A second “bivalent” coronavirus vaccine has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for individuals aged 12 and over.
The regulator confirmed on Saturday that Pfizer/BioNTech’s vaccine had met its standards of safety, quality and effectiveness and had been approved for the UK autumn booster programme.The regulator confirmed on Saturday that Pfizer/BioNTech’s vaccine had met its standards of safety, quality and effectiveness and had been approved for the UK autumn booster programme.
The vaccine, which targets the original variant of coronavirus and the Omicron variant that emerged at the end of 2021, follows the approval of a similar booster from Moderna in August.The vaccine, which targets the original variant of coronavirus and the Omicron variant that emerged at the end of 2021, follows the approval of a similar booster from Moderna in August.
The decision to approve the vaccine was based on data from a clinical trial, which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against Omicron and the original strain.The decision to approve the vaccine was based on data from a clinical trial, which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against Omicron and the original strain.
Throughout the trial, safety monitoring of side-effects observed showed they were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, with no new serious safety concerns identified.Throughout the trial, safety monitoring of side-effects observed showed they were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, with no new serious safety concerns identified.
Dr June Raine, the MHRA chief executive, said: “I am pleased to announce that we now have a second approved vaccine for the UK autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.Dr June Raine, the MHRA chief executive, said: “I am pleased to announce that we now have a second approved vaccine for the UK autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.
“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants.”“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants.”
Pfizer’s UK country president, Susan Rienow, said: “We are delighted with today’s approval by the MHRA of Pfizer/BioNTech’s Omicron BA.1-adapted bivalent Covid-19 vaccine.Pfizer’s UK country president, Susan Rienow, said: “We are delighted with today’s approval by the MHRA of Pfizer/BioNTech’s Omicron BA.1-adapted bivalent Covid-19 vaccine.
“We have been following the science since the beginning of the pandemic and are pleased to be able to provide the National Health Service with another tool in the armoury.“We have been following the science since the beginning of the pandemic and are pleased to be able to provide the National Health Service with another tool in the armoury.
“We have been manufacturing the new vaccine at risk (ahead of approval being granted), and doses will be shipped immediately for use in the autumn booster programme to help protect people in the UK this winter season.”“We have been manufacturing the new vaccine at risk (ahead of approval being granted), and doses will be shipped immediately for use in the autumn booster programme to help protect people in the UK this winter season.”
Prof Wei Shen Lim, the chair of Covid-19 immunisation on the Joint Committee on Vaccination and Immunisation (JCVI), said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.”Prof Wei Shen Lim, the chair of Covid-19 immunisation on the Joint Committee on Vaccination and Immunisation (JCVI), said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.”
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Adding that winter was typically the time of greatest threat from respiratory infections, Lim encouraged everyone who was eligible to have their booster vaccine this autumn when it was offered, adding: “This is our best defence against becoming severely ill from Covid-19.”Adding that winter was typically the time of greatest threat from respiratory infections, Lim encouraged everyone who was eligible to have their booster vaccine this autumn when it was offered, adding: “This is our best defence against becoming severely ill from Covid-19.”
The health secretary, Steve Barclay, said: “Our vaccination programme has already saved countless lives, but it is absolutely vital we are not complacent as winter approaches.The health secretary, Steve Barclay, said: “Our vaccination programme has already saved countless lives, but it is absolutely vital we are not complacent as winter approaches.
“I have therefore accepted the advice of the independent JCVI to add a Pfizer bivalent vaccine to our autumn Covid booster rollout.“I have therefore accepted the advice of the independent JCVI to add a Pfizer bivalent vaccine to our autumn Covid booster rollout.
“If eligible, please come forward for a booster jab as soon as you are contacted by the NHS.”“If eligible, please come forward for a booster jab as soon as you are contacted by the NHS.”